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NCT00833560 · OUTCOME

Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)

A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy · Source last updated 2014-11-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to Day 63

What was measured

CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.

Analysis population: Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).

Groups in this outcome

Cyclophosphamide + Bortezomib + Dexamethasone

Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cyclophosphamide + Bortezomib + Dexamethasone391

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cyclophosphamide + Bortezomib + Dexamethasone334Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    81.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    88.8
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Percentage of participants with response
    param Value
    85.4
    statistical Method
    Two - sided binomial test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    81.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    88.8
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Percentage of participants with response
    param Value
    85.4
    statistical Method
    Two - sided binomial test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        334
denoms
  1. counts
    1. group Id
      OG000
      value
      391
    units
    Participants
description
CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
groups
  1. description
    Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
    id
    OG000
    title
    Cyclophosphamide + Bortezomib + Dexamethasone
param Type
NUMBER
population Description
Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).
reporting Status
POSTED
time Frame
Up to Day 63
title
Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice